Ignite Creation Date:
2025-12-24 @ 7:52 PM
Ignite Modification Date:
2026-01-02 @ 6:08 AM
Study NCT ID:
NCT03787004
Status:
COMPLETED
Last Update Posted:
2018-12-26
First Post:
2018-12-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Placebo-Controlled, Two-Part Study, Oral Dose to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of CNTX-6970 in Healthy Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D059350', 'term': 'Chronic Pain'}, {'id': 'D059226', 'term': 'Nociceptive Pain'}], 'ancestors': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'Part 1: Open Label Part 2: Double-Blind'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 62}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-08-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-12', 'completionDateStruct': {'date': '2018-09-26', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-12-21', 'studyFirstSubmitDate': '2018-12-21', 'studyFirstSubmitQcDate': '2018-12-21', 'lastUpdatePostDateStruct': {'date': '2018-12-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-12-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-08-19', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'CNTX-6970 Pharmacokinetics - fasted state or high-fat standardized meal', 'timeFrame': 'Up to Day 3', 'description': 'Food effects on pharmacokinetics of CTNX-6790 for Part 1 participants'}, {'measure': 'CNTX-6970 Pharmacokinetics - AUC0-t', 'timeFrame': 'Up to Day 13', 'description': 'Systemic exposure to CNTX-6970 measured by AUC0-t'}, {'measure': 'CNTX-6970 Pharmacokinetics - AUC0-inf', 'timeFrame': 'Up to Day 13', 'description': 'Systemic exposure to CNTX-6970 measured by AUC0-inf'}, {'measure': 'CNTX-6970 Pharmacokinetics - Cmax', 'timeFrame': 'Up to Day 13', 'description': 'Systemic exposure to CNTX-6970 measured by Cmax'}, {'measure': 'CNTX-6970 Pharmacokinetics - tmax', 'timeFrame': 'Up to Day 13', 'description': 'Systemic exposure to CNTX-6970 measured by tmax'}, {'measure': 'CNTX-6970 Pharmacokinetics - t1/2', 'timeFrame': 'Up to Day 13', 'description': 'Systemic exposure to CNTX-6970 measured by t1/2'}], 'secondaryOutcomes': [{'measure': 'Incidence of treatment-emergent adverse events (TEAEs) (safety and tolerability)', 'timeFrame': 'Up to Day 13', 'description': 'Number of participants with TEAEs, which includes laboratory test variables'}, {'measure': 'CNTX-6970 Pharmacodynamics - Emax', 'timeFrame': 'Up to Day 13', 'description': 'Pharmacodynamic effect on MCP-1 and RANTES measured by Emax'}, {'measure': 'CNTX-6970 Pharmacodynamics - PD tmax', 'timeFrame': 'Up to Day 13', 'description': 'Time to maximum pharmacodynamic effect on MCP-1 and RANTES measured by tmax'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Chronic Pain', 'Nociceptive Pain', 'Mixed Pain'], 'conditions': ['Chronic Pain', 'Nociceptive Pain']}, 'descriptionModule': {'briefSummary': 'A Phase 1, placebo-controlled, two part study with either single dose or multiple increasing oral dose to evaluate the safety, pharmacokinetics, and pharmacodynamics of CNTX-6970 in healthy subjects.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '64 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Key Inclusion Criteria:\n\n* Is in good general health as determined by the Investigator's review\n* Has a body mass index (BMI) between 18 and 35kg/m\\^2, inclusive\n* For females, is not currently pregnant or breastfeeding and is either of non-childbearing potential or willing to use an adequate method of birth control\n* For males, must agree to use barrier contraception and not to donate sperm\n\nKey Exclusion Criteria:\n\n* Has a history of cardiac disease, including congestive heart failure, angina, or any arrhythmia\n* Has diabetes mellitus, acromegaly, clinically active thyroid disease, or other active endocrinopathy\n* Has any history or currently active type of cancer except excised or cured basal cell carcinoma\n* Has a gastrointestinal disorder that could interfere with the absorption of orally administered drugs\n* Has asthma or other severe respiratory disease (e.g., chronic obstructive pulmonary disease) requiring daily prescription medicine\n* Currently has kidney, neurologic, metabolic, or liver disease, or other organ system disease\n* Has a history, current evidence, or is being treated for depression, suicidal ideation, suicide attempt, or any other current psychiatric condition requiring active treatment\n* Has an immunological disorder such as, but not limited to, human immunodeficiency virus (HIV), acquired, or congenital immune deficiency syndrome; autoimmune diseases, such as, but not limited to, rheumatoid arthritis, systemic lupus erythematosus, seronegative spondyloarthropathies or vasculitis, or any infection\n* Has positive screening test for hepatitis B virus (HBV) or hepatitis C virus (HCV);\n* Is pregnant, lactating, or planning a pregnancy during the study\n* Has used any prescribed medication within 30 days prior to the first admission or has plans to use any prescribed medication during the study (with the exception of hormonal contraceptives)\n* Has used within 14 days prior to the first admission or has plans to use during the study any over-the-counter medicinal products, including herbal and dietary supplements (except for occasional use of acetaminophen or NSAIDs, such as ibuprofen or naproxen; calcium; or Vitamin D)\n* Use of any of the following:\n\n * Human growth hormone, octreotide, anti-diabetic medication, or thyroid suppressors or supplements\n * Immunosuppressive drugs within 30 days of study start, or 5 half-lives of the drug (whichever is longer), or plans to use during the study"}, 'identificationModule': {'nctId': 'NCT03787004', 'briefTitle': 'A Placebo-Controlled, Two-Part Study, Oral Dose to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of CNTX-6970 in Healthy Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'Centrexion Therapeutics'}, 'officialTitle': 'A Placebo-Controlled, Two-Part Study With Single Dose and Multiple Ascending Oral Dose to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of CNTX-6970 in Healthy Subjects', 'orgStudyIdInfo': {'id': 'CNTX-6970-HV-102'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Part 1 Cohort 1 (Single Dose)', 'description': 'Single 100 mg oral dose of CNTX-6970 (film-coated tablet or enteric-coated tablet)', 'interventionNames': ['Drug: CNTX-6970']}, {'type': 'EXPERIMENTAL', 'label': 'Part 1 Cohort 2 (Single Dose)', 'description': 'Single 100 mg oral dose of CNTX-6970 film-coated tablet', 'interventionNames': ['Drug: CNTX-6970']}, {'type': 'EXPERIMENTAL', 'label': 'Part 2 (Multiple Ascending Dose)', 'description': '100 mg, 300 mg, and 600 mg CNTX-6970 oral tablet', 'interventionNames': ['Drug: CNTX-6970']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Part 2 Placebo', 'description': 'Placebo oral tablet', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': 'CNTX-6970', 'type': 'DRUG', 'description': 'Oral dose CNTX-6970', 'armGroupLabels': ['Part 1 Cohort 1 (Single Dose)', 'Part 1 Cohort 2 (Single Dose)', 'Part 2 (Multiple Ascending Dose)']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'Oral dose placebo', 'armGroupLabels': ['Part 2 Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '45227', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'Medpace Clinical Pharmacology Unit', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}], 'overallOfficials': [{'name': 'Randall M. Stevens, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Centrexion Therapeutics'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centrexion Therapeutics', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}